Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06234371 |
| Other study ID # |
21-05-6633 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2, 2024 |
| Est. completion date |
January 2, 2028 |
Study information
| Verified date |
January 2024 |
| Source |
University of Notre Dame |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Recovery Resource Council (RRC) is one of the largest and most comprehensive non-profit
mental and behavioral healthcare providers in North Texas. Accredited by the Joint Commission
in Behavioral Health and licensed by the State of Texas as an Outpatient Treatment Center,
RRC strives to promote wellness and recovery through a variety of services and programming.
An important component of RRC programming is providing free counseling services to hundreds
of U.S. veterans annually. While RRC observes great success for veterans who complete
counseling, attendance can be a major obstacle.
Veterans who approach RRC for individual counseling services and consent to participate will
be randomly assigned to the treatment or control group. The control group will receive
counseling as usual. The treatment group will receive $500 gift card payments upon completing
their 6th, 12th, and 18th counseling sessions, i.e., $1,500 in gift cards for completing all
18 sessions, the usual prescribed length of therapy. Our primary focus is to examine the
impact of the financial incentives on therapy attendance and attrition. In addition, the
investigators will estimate the impact on mental health using mental health inventories
collected over the course of therapy sessions.
Description:
Study enrollment will occur starting in September 2023 and will continue through 2026.
Veterans who are referred to RRC are subject to an eligibility screening via phone, during
which time they must ensure that they are 18 years of age or older, hold veteran status, are
deemed not suicidal by RRC staff, and will participate in individual counseling. Eligible
veterans are then assigned an intake session time, during which they show any requested
documentation, complete the standard RRC intake form, complete an initial mental health
assessment, and go through the informed consent process with RRC staff. Any participant who
does not want to participate in the study will still receive all services as usual. After a
participant gives consent, they are enrolled in the study and complete additional intake
questions via the Qualtrics platform. Randomization will be done through the Qualtrics
platform, so that results can be communicated to veterans immediately during their intake
session. Randomization odds will be 50-50. The investigators plan to enroll 600 individuals,
of which approximately 300 individuals will be offered financial incentives for therapy.
The experimental portion of these procedures is the random assignment of individuals to be
offered or to not be offered financial incentives for therapy. The treatment group will be
offered a $500 gift card for completing 6, 12, and 18 counseling sessions; up to $1,500 in
total. Because RRC's typical practice involves prescribing and scheduling counseling in
6-session blocks, the financial awards are revealed to veterans in the treatment group in
stages. After intake, treatment group individuals are told that they will receive a $500 gift
card for completing the first 6 sessions; later sessions and awards are not mentioned. If the
counselor decides that another 6-session block should be prescribed, then at the completion
of the 5th session (i) the next 6 sessions are scheduled (i.e., sessions 7 through 12) and
(ii) the counselor reveals that the participant can earn another $500 for completing the 12th
session. The same process takes place during session 11. As part of RRC's typical practice,
no veterans are offered more than 18 sessions. The counseling received by the control group
is identical to that of the treatment group, as is the scheduling of additional sessions.
During the consent process, participants consent to be followed in administrative records.
The investigators will track several outcomes of interest as they become available using
several sources:
1. A start-of-session mental health survey administered via Qualtrics. This survey
pre-dates our study and is part of RRC's usual process.
2. An end-of-session survey on expected benefits and expected costs of continuing
counseling administered via Qualtrics. These questions were designed by the researchers.
3. Clinical mental health screenings performed by the licensed therapists after 6, 12, and
18 sessions. The practice of collecting this information pre-dates our study and is part
of RRC's usual process.
At the point that 300 individuals are enrolled in the study sample, the investigators plan to
estimate the treatment effect to determine the feasibility of adding a third study arm. If
the treatment effect on either average number of sessions completed or the probability of
completing six sessions is sufficiently large and there is support from RRC to do so, the
investigators plan to begin randomizing into a second treatment arm which will receive a gift
card of value less than $500. If this third study arm becomes a reality, power calculations
will be re-evaluated to shift to an updated optimal sample size.
